Diabetes mellitus type 2 or type 2 diabetes (formerly called non-insulin-dependent diabetes mellitus (NIDDM), or adult-onset diabetes) is a disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency. While it is often initially managed by increasing exercise and dietary modifications, medications are typically needed as the disease progresses. There are an estimated 23.6 million people in the U.S. (7.8% of the population) with diabetes, 90% of whom are type 2. Worldwide, it is estimated that at least 171 million people suffer from type 2 diabetes. With prevalence rates doubling between 1990 and 2005, CDC has characterized the increase as an epidemic. In addition, while traditionally considered a disease of adults, type 2 diabetes is increasingly diagnosed in children in parallel to rising obesity rates due to alterations in dietary patterns as well as in life styles during childhood.
Hyperglycemia plays an important role in the pathogenesis of type 2 diabetes by means of glucotoxicity. Thus, effective glycemic control not only reduces the incidence of microvascular complications but also corrects the metabolic abnormalities that contribute to the progression of the disease. Plasma glucose is normally filtered in the kidney in the glomerulus and actively reabsorbed in the proximal tubule. The sodium dependent glucose transporter (SGLT2) appears to be the major transporter responsible for the reuptake of glucose at this site. Thus, a selective inhibitor of SGLT2 in the kidney is expected to normalize plasma glucose levels by enhancing the excretion of glucose in the urine, thereby improving insulin sensitivity, and delaying the development of diabetic complications, in the absence of significant gastrointestinal side effects.
Dapagliflozin is an orally active SGLT2 inhibitor that is disclosed in U.S. Pat. No. 6,515,117.

U.S. Pat. No. 6,515,117 describes the synthesis of dapagliflozin from the corresponding tetraacetylated β-C-glucoside precursor. After removal of the acetate moieties, the residue was dissolved in EtOAc, washed with brine containing KHSO4 and dried. The volatile solvents were removed and the resultant oil in a minimum amount of CH2Cl2 was foamed under vacuum to give the desired title compound described as a glassy off white solid containing 0.11 mol % of EtOAc.
A new crystalline or amorphous form of a compound may possess physical properties that differ from, and are advantageous over, those of other crystalline or amorphous forms. These include, packing properties such as molar volume, density and hygroscopicity; thermodynamic properties such as melting temperature, vapor pressure and solubility; kinetic properties such as dissolution rate and stability under various storage conditions; surface properties such as surface area, wettability, interfacial tension and shape; mechanical properties such as hardness, tensile strength, compactibility, handling, flow and blend; and filtration properties. Variations in any one of these properties may affect the chemical and pharmaceutical processing of a compound as well as its bioavailability and may often render the new form advantageous for pharmaceutical and medical use.
PCT International Patent Publication No. WO 2008/002824 discloses crystalline solvates and complexes of dapagliflozin, namely (S)-propylene glycol ((S)-PG) hydrate (Form SC-3), (R)-propylene glycol ((R)-PG) hydrate (Form SD-3), EtOH dihydrate (Form SA-I), ethylene glycol (EG) dihydrate (Form SB-I), ethylene glycol (EG) dihydrate (Form SB-2), 1:2 L-proline complex (Form 3), 1:1 L-proline complex (Form 6), 1:1 L-proline hemihydrate complex (Form H.5-2), and 1:1 L-phenylalanine complex (Form 2).
U.S. Pat. Nos. 7,851,502 and 8,221,786 disclose pharmaceutical compositions comprising dapagliflozin propylene glycol (PG) hydrate.
There still remains an unmet need for solid state forms of dapagliflozin having good physicochemical properties, desirable bioavailability, and advantageous pharmaceutical parameters.